Medical device capable of injection, cutting and coagulation
Summary by NHIP
Tissue treatment device with sliding needle
The device treats tissue using a catheter with a lumen containing a sliding needle that moves between retracted and extended positions. In the retracted state, a conductive pad connects the needle to a second electrode for bipolar operation, while the extended state allows the needle to contact a first electrode for monopolar cutting.
Claim Score by NHIP
Abstract
A device for treating tissue includes a catheter including an elongated body extending from a proximal end to a distal end and including a lumen extending therethrough, a distal tip connected to the distal end of the elongated body and including a first electrode and a second electrode extending thereabout, the first electrode extending to a distal opening of the lumen and a first needle extending longitudinally from a proximal end to a distal end, the first needle slidably received within the lumen of the catheter to be moved between a retracted bipolar configuration, in which the distal end of the needle is proximal the distal opening of the catheter, and an extended monopolar configuration, in which the distal end of the first needle extends distally past the distal opening of the catheter so that the first needle contacts the first electrode and is configured to cut tissue.

Term
12.8 yearsleft in the term
Expires 17 July 2039, including 910 days of term adjustment.
- Priority and filed
- Granted
- Today
- Expires
18 claims: 3 independent, 15 dependent
- 1Broadest claimClaim Score 57, average(NHIP)A device for treating tissue, comprising:a catheter including an elongated body and a distal tip, the elongated body extending from a proximal end to a distal end and including a lumen extending therethrough, the distal tip connected to the distal end of the elongated body and including a first electrode and a second electrode extending thereabout, the first electrode extending to a distal opening of the lumen;and a first needle extending longitudinally from a proximal end to a distal end, the first needle slidably received within the lumen of the catheter to be moved between a retracted bipolar configuration, in which the distal end of the needle is proximal of the distal opening of the catheter and a proximal portion of the first needle is connected to the second electrode via a conductive pad biased against the first needle, and an extended monopolar configuration, in which the distal end of the first needle extends distally past the distal opening of the catheter so that the first needle contacts the first electrode and is configured to cut tissue.
- 13A system for treating target tissue, comprising:a catheter including an elongated body and a distal tip, the elongated body extending from a proximal end to a distal end and including a lumen extending therethrough, the distal tip connected to the distal end of the elongated body and including a first electrode and a second electrode extending thereabout, the first electrode extending to a distal opening of the lumen;a power source supplying a current to the first electrode;a needle extending longitudinally from a proximal end to a distal end, the needle slidably received within the lumen of the catheter to be moved between a retracted bipolar configuration, in which the distal end of the needle is proximal the distal opening of the catheter so that when the distal tip is pressed against the target tissue the current is passed from the first electrode to the second electrode to coagulate the target tissue and a proximal portion of the needle is connected to the second electrode via a conductive pad biased against the needle, and an extended monopolar configuration, in which the distal end of the needle extends distally past the distal opening of the catheter so that the needle contacts the first electrode and inactivates the second electrode to cut the target tissue;and a handle assembly connected to the proximal end of the catheter and including an actuator for moving the needle between the retracted bipolar configuration and the extended monopolar configuration.
- 14A method for treating tissue, comprising:inserting a catheter of a device into a living body until a distal tip thereof is proximate a target site, the distal tip including a first electrode and a second electrode extending thereabout;providing current to the first electrode and pressing the distal tip against a first tissue at the target site;moving a needle housed within the catheter from a retracted bipolar configuration, in which a distal end of the needle is proximal a distal opening of a lumen of the catheter and a proximal portion of the needle is connected to the second electrode via a conductive pad biased against the needle, to an extended monopolar configuration, in which the distal end of the needle extends distally past the distal opening of the lumen to contact the first electrode which extends to the distal opening;and pressing the distal end of the needle against a second target tissue at the target site to cut the second target tissue.
Independent claims3
56 paragraphs in 5 sections, as filed
PRIORITY CLAIM
0001This present application is a Continuation of pending U.S. patent application Ser. No. 15/409,255 filed Jan. 18, 2017, which claims priority to U.S. Provisional Patent Application Ser. No. 62/287,207 filed Jan. 26, 2016; the disclosure of which is incorporated herewith by reference
BACKGROUND
0002Physicians have become more willing to perform more aggressive interventional and therapeutic endoscopic procedures including, for example, removal of larger lesions (e.g., cancerous masses), tunneling under mucosal layers in the gastro-intestinal (GI) tract to treat tissues below the mucosa, full thickness removal of tissue, inserting devices through the GI tract and then penetrating the GI organ to treat tissue outside the GI tract, and endoscopic treatment/repair of post-surgical issues (e.g., post-surgical leaks, breakdown of surgical staple lines, anastomotic leaks). These procedures may increase the risk of perforating or damaging the wall of the GI tract, or may require closure of the GI tract wall as part of the procedure. One method for sealing potential hemorrhaging or bleeding areas is via electrical coagulation of the target site. An electro-coagulation device may be inserted through the endoscope to the target site. In some cases, however, additional treatment of the tissue (e.g., ablation, cutting) may be necessary to treat the target site so that physicians may be required to use different devices to treat the target site as desired. The exchange of different devices through the endoscope may be time consuming, may increase the risk to the patient and may also increase patient discomfort.
SUMMARY
0003The present disclosure is directed to a device for treating tissue, comprising a catheter including an elongated body and a distal tip, the elongated body extending from a proximal end to a distal end and including a lumen extending therethrough, the distal tip connected to the distal end of the elongated body and including a first electrode and a second electrode extending thereabout, the first electrode extending to a distal opening of the lumen, and a first needle extending longitudinally from a proximal end to a distal end, the first needle slidably received within the lumen of the catheter to be moved between a retracted bipolar configuration, in which the distal end of the needle is proximal the distal opening of the catheter, and an extended monopolar configuration, in which the distal end of the first needle extends distally past the distal opening of the catheter so that the first needle contacts the first electrode and is configured to cut tissue.
0004In one embodiment, the first electrode may be connected to a power source supplying a current thereto.
0005In one embodiment, the second electrode may be electrically connected to a proximal portion of the first needle to provide a return path for the current.
0006In one embodiment, the second electrode may be connected to the proximal portion of the first needle via a conductive pad biased against the first needle.
0007In one embodiment, the first needle may be formed of a conductive material and may include an insulated portion which, when the first needle is in the extended monopolar configuration extends over the conductive pad to break the return path and inactivate the second electrode.
0008In one embodiment, the first needle may include a channel extending longitudinally therethrough and the proximal end of the needle may be configured to be coupled to one of a fluid source and a vacuum source.
0009In one embodiment, the first needle may be formed of a non-conductive material and may include a metal strip extending along a length thereof.
0010In one embodiment, the first needle may include a non-conductive elongated body and at least one conductive wing extending laterally therefrom.
0011In one embodiment, the distal tip may be tapered so that the first electrode extends to a sharp tip thereof to concentrate a current density thereto.
0012In one embodiment, the first electrode may extend about the distal opening of the lumen.
0013In one embodiment, the first electrode may extend proximally into the lumen from the distal opening.
0014In one embodiment, the first and second electrode may extend helically about the distal tip and may be separated from one another by an insulated portion.
0015In one embodiment, the device may further comprise a second needle slidably received within a channel of the first needle, a distal end of the second needle configured to cauterize tissue.
0016In one embodiment, the distal end of the second needle may be one of hook-shaped, cross-shaped and circular.
0017The present disclosure is also directed to a system for treating target tissue, comprising a catheter including an elongated body and a distal tip, the elongated body extending from a proximal end to a distal end and including a lumen extending therethrough, the distal tip connected to the distal end of the elongated body and including a first electrode and a second electrode extending thereabout, the first electrode extending to a distal opening of the lumen and a power source supplying a current to the first electrode. The system also comprises a needle extending longitudinally from a proximal end to a distal end, the needle slidably received within the lumen of the catheter to be moved between a retracted bipolar configuration, in which the distal end of the needle is proximal the distal opening of the catheter so that when the distal tip is pressed against the target tissue the current is passed from the first to second electrode to coagulate the target tissue, and an extended monopolar configuration, in which the distal end of the needle extends distally past the distal opening of the catheter so that the needle contacts the first electrode and inactivates the second electrode to cut the target tissue, and a handle assembly connected to the proximal end of the catheter and including an actuator for moving the needle between the retracted bipolar configuration and the extended monopolar configuration.
0018The present disclosure is also directed to a method for treating tissue, comprising inserting a catheter of a device into a living body until a distal tip thereof is proximate a target site, the distal tip including a first electrode and a second electrode extending thereabout, providing current to the first electrode and pressing the distal tip against a first tissue at the target site, moving a needle housed within the catheter from a retracted bipolar configuration, in which a distal end of the needle is proximal a distal opening of a lumen of the catheter, to an extended monopolar configuration, in which the distal end of the needle extends distally past the distal opening of the lumen to contact the first electrode which extends to the distal opening, and pressing the distal end of the needle against a second target tissue at the target site to cut the second target tissue.
0019In one embodiment, the method may further comprise injecting one of a fluid and a drug through a channel of the needle to the target site.
0020In one embodiment, the method may further comprise providing a suctioning force through a channel of the needle.
0021In one embodiment, pressing the distal tip against the first tissue may coagulate the first tissue.
0022In one embodiment, a distal end of the distal tip is tapered so that pressing the distal tip against the first tissue cuts the first tissue.
BRIEF DESCRIPTION
0023<figref idref="DRAWINGS">FIG. <b>1</b>A</figref> shows a longitudinal side view of a device according to an exemplary embodiment of the present disclosure;
0024<figref idref="DRAWINGS">FIG. <b>1</b>B</figref> shows a longitudinal side view of a device according to another exemplary embodiment of the present intention.
0025<figref idref="DRAWINGS">FIG. <b>2</b></figref> shows a front view of the device of <figref idref="DRAWINGS">FIG. <b>1</b>A</figref>, from a distal end of the device along a longitudinal axis of the device;
0026<figref idref="DRAWINGS">FIG. <b>3</b></figref> shows an enlarged longitudinal cross-sectional view of a distal portion of the device of <figref idref="DRAWINGS">FIG. <b>1</b>A</figref>, in an extended monopolar configuration;
0027<figref idref="DRAWINGS">FIG. <b>4</b></figref> shows an enlarged longitudinal cross-sectional view of the distal portion of the device of <figref idref="DRAWINGS">FIG. <b>1</b>A</figref>, in a retracted bipolar configuration;
0028<figref idref="DRAWINGS">FIG. <b>5</b></figref> shows a partial longitudinal cross-sectional view of a proximal portion of the device of <figref idref="DRAWINGS">FIG. <b>1</b>A</figref>, in the bipolar configuration;
0029<figref idref="DRAWINGS">FIG. <b>6</b></figref> shows a partial longitudinal cross-sectional view of the proximal portion of the device of <figref idref="DRAWINGS">FIG. <b>1</b>A</figref>, in the monopolar configuration;
0030<figref idref="DRAWINGS">FIG. <b>7</b></figref> shows a longitudinal side view of a needle according to an alternate embodiment of the present disclosure;
0031<figref idref="DRAWINGS">FIG. <b>8</b></figref> shows a perspective view of a needle according to another alternate embodiment of the present disclosure;
0032<figref idref="DRAWINGS">FIG. <b>9</b>A</figref> shows a longitudinal side view of a device according to another exemplary embodiment of the present disclosure;
0033<figref idref="DRAWINGS">FIG. <b>9</b>B</figref> shows a longitudinal side view the device of <figref idref="DRAWINGS">FIG. <b>9</b>A</figref> according to an alternate embodiment of the present disclosure;
0034<figref idref="DRAWINGS">FIG. <b>9</b>C</figref> shows a longitudinal side view the device of <figref idref="DRAWINGS">FIG. <b>9</b>A</figref> according to another alternate embodiment of the present disclosure;
0035<figref idref="DRAWINGS">FIG. <b>9</b>D</figref> shows a longitudinal side view the device of <figref idref="DRAWINGS">FIG. <b>9</b>A</figref> according to yet another alternate embodiment of the present disclosure;
0036<figref idref="DRAWINGS">FIG. <b>9</b>E</figref> shows a longitudinal side view the device of <figref idref="DRAWINGS">FIG. <b>9</b>A</figref> according to another alternate embodiment of the present disclosure;
0037<figref idref="DRAWINGS">FIG. <b>10</b></figref> shows a longitudinal side view of a device according to yet another exemplary embodiment of the present disclosure; and
0038<figref idref="DRAWINGS">FIG. <b>11</b></figref> shows a longitudinal side view of a catheter according to an alternate embodiment of the present disclosure.
DETAILED DESCRIPTION
0039The present disclosure may be further understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals. The present disclosure relates to endoscopic devices and, in particular, endoscopic devices capable of injecting, cutting and coagulation. Exemplary embodiments of the present disclosure describe a device movable between a monopolar configuration and a bipolar configuration so that the device is capable of use for both cutting and coagulation of tissue. In particular, exemplary embodiments describe a catheter including a distal tip with a pair of electrodes for bipolar electrical activation to coagulate tissue. A needle is slidable through the catheter so that, when the needle is extended distally out of the catheter, a return path of the bipolar configuration is blocked, and the needle has a monopolar electrical activation to cut tissue. Thus, a single device is capable of achieving multiple tissue treatments. It should be noted that the terms “proximal” and “distal”, as used herein, are intended to refer to a direction toward (proximal) and away from (distal) a user of the device.
0040As shown in <figref idref="DRAWINGS">FIGS. <b>1</b>-<b>6</b></figref>, a device <b>100</b> for treating a target tissue comprises a catheter <b>102</b> including a lumen <b>104</b> extending longitudinally therethrough and a distal tip <b>106</b>. The distal tip <b>106</b> includes a first electrode <b>108</b> and a second electrode <b>110</b> wound thereabout (e.g., circumferentially around the distal tip) and separated from one another by an electrically insulative material to form a bipolar arrangement. Thus, when the distal tip <b>106</b> is pressed against target tissue, energy may be provided to the distal tip <b>106</b> to heat and coagulate the target tissue. The device <b>100</b> further comprises a needle <b>116</b> slidably received within the lumen <b>104</b> of the catheter <b>102</b> and movable between an extended monopolar configuration in which a distal end <b>118</b> of the needle <b>116</b> extends distally from the lumen <b>104</b> and a retracted bipolar configuration in which the distal end <b>118</b> is withdrawn proximal into the lumen <b>104</b> via a distal opening <b>120</b>. In the monopolar configuration, the needle <b>116</b> acts alone as a monopolar electrode while, in the bipolar configuration, the first and second electrodes <b>108</b>, <b>110</b>, respectively, operate together to apply bipolar energy to target tissue. As will be described in further detail below, the first (e.g., positive) electrode <b>108</b> is structured so that it extends to the distal opening <b>120</b> of the lumen <b>104</b> and, when the needle <b>116</b> is in the extended configuration, the needle <b>116</b> contacts the first electrode <b>108</b>. Extension of the needle <b>116</b> to the extended configuration may also break a return path of the second electrode <b>110</b> so that the first electrode <b>108</b> provides monopolar activation of the needle <b>116</b>. Thus, the needle <b>116</b>, in the extended monopolar configuration, may be energized to cut target tissue when pressed thereagainst. When the needle <b>116</b> is in the retracted configuration, however, the first and second electrodes <b>108</b>, <b>110</b> may be energized to provide bipolar activation of the distal tip <b>106</b> to coagulate tissue. In one embodiment, the needle <b>116</b> may be hollow, including a channel <b>122</b> extending therethrough so that the channel <b>122</b> may be used to pass fluid therethrough. Thus, the device <b>100</b>, in various configurations, may be capable of injecting, cutting and/or coagulation. The device <b>100</b> enables a user (e.g., physician) to utilize multiple treatment options without having to remove, replace or insert additional devices.
0041The catheter <b>102</b> includes an elongated body <b>103</b> extending longitudinally from a proximal end <b>112</b> to a distal end <b>124</b> and a distal tip <b>106</b> at the distal end <b>124</b> of the elongated body <b>103</b>. The lumen <b>104</b> extends longitudinally through the catheter <b>102</b>, through both the elongated body <b>103</b> and the distal tip <b>106</b> to the distal opening <b>120</b> and is sized and shaped to slidably receive the needle <b>116</b> therein. The elongated body <b>103</b> may be sufficiently flexible so that the catheter <b>102</b> may be inserted through even tortuous paths of a living body via, for example, a working channel of an endoscope. The proximal end of the catheter <b>102</b> may be attached to a handle assembly <b>132</b> which includes an actuator (not shown) for moving the needle <b>116</b> between the extended monopolar configuration and the retracted bipolar configuration.
0042As would be understood by those skilled in the art, the distal tip <b>106</b> may be formed of any suitable biocompatible, electrically insulative material such as a ceramic with the first and second electrodes <b>108</b>, <b>110</b> extending helically or spirally thereabout in the distal tip <b>106</b>. The first and second electrodes <b>108</b>, <b>110</b> may be formed of any suitable electrically conductive, biocompatible material such as, for example, gold. The first and second electrodes <b>108</b>, <b>110</b> may be separated from one another via one or more electrically insulative areas <b>130</b>. The bipolar electrode structure of the catheter <b>102</b> may be substantially similar to the electrode structure of the GOLD PROBE™ electrohemostasis catheter and of U.S. Pat. No. 5,403,311, the entire disclosure of which is incorporated herein by reference. As shown in <figref idref="DRAWINGS">FIGS. <b>2</b>-<b>4</b></figref>, the first electrode <b>108</b>, however, may extend to the distal end of the distal tip <b>106</b> to at least partially surround the distal opening <b>120</b> of the catheter <b>102</b> so that the first electrode <b>108</b> contacts the needle <b>116</b>, when the needle <b>116</b> is in the extended configuration. In a further embodiment, the first electrode <b>108</b> may also extend proximally into the lumen <b>104</b> from the distal opening <b>120</b>. The first and second electrodes <b>108</b>, <b>110</b> may extend about and/or along the distal tip <b>106</b> in any of a variety of other configurations (e.g., longitudinal strips, circumferential bands, helical windings, etc.) so long as the first electrode <b>108</b> extends to the distal opening <b>120</b> of the catheter <b>102</b> to contact the needle <b>116</b>, when the needle <b>116</b> is in the extended configuration.
0043A distal end <b>128</b> of the distal tip <b>106</b> may have any of a variety of configurations. In one exemplary embodiment, the distal face <b>128</b> may be rounded (e.g., hemispherical). In another embodiment, the distal face <b>128</b> may be substantially planar. The distal face <b>128</b> may have any of a variety of shapes so long as the distal tip <b>106</b> is configured to coagulate tissue with which it is in contact when energized.
0044As shown in <figref idref="DRAWINGS">FIGS. <b>5</b> and <b>6</b></figref>, the first electrode <b>108</b> may be powered via a power source <b>136</b> connected to a proximal end of the device <b>100</b>. The second electrode <b>110</b> may be electrically connected to a conductive pad <b>138</b> pressed into contact with a proximal portion of the needle <b>116</b>, which is housed within the handle assembly <b>132</b>, to provide a return path for the current. In one exemplary embodiment, the pad <b>138</b> may be biased toward the needle <b>116</b> via, for example, a spring or other biasing element. In other embodiments, however, the return may be connected to the needle <b>116</b> in any of a number of different ways. For example, the return may be connected to the needle <b>116</b> via a ring, a support built into the handle assembly <b>132</b>, a clip, etc.
0045The needle <b>116</b> extends longitudinally from a proximal end <b>114</b> to the distal end <b>118</b> and includes the channel <b>122</b> extending longitudinally therethrough. The needle <b>116</b> is slidably received within the lumen <b>104</b> so that the needle <b>116</b> is movable relative thereto between the extended monopolar configuration and the retracted bipolar configuration. The proximal end <b>114</b> may extend proximally from the proximal end <b>112</b> of the catheter <b>102</b> so that the proximal end <b>114</b> extends through the handle assembly <b>132</b>. The proximal end <b>114</b> may extend proximally from the handle assembly <b>132</b> and may be configured to be connected to a fluid source for the injection of fluids and/or drugs. In another embodiment, the proximal end <b>114</b> may be connected to a vacuum source which may apply a suction force therethrough. A proximal portion of the needle <b>116</b> is connected to an actuator of the handle assembly <b>132</b> so that the needle <b>116</b> may be moved between the monopolar and bipolar configurations via the actuator. The distal end <b>118</b> of the needle <b>116</b>, as shown in <figref idref="DRAWINGS">FIG. <b>1</b>A</figref>, may include a tapered tip for facilitating cutting of tissue when the distal end <b>118</b> of the needle <b>116</b> is pressed against tissue. Alternatively, as shown in <figref idref="DRAWINGS">FIG. <b>1</b>B</figref>, a distal end <b>118</b>′ needle <b>116</b>′ may be non-tapered so that a distal face <b>119</b>′ thereof is substantially perpendicular to a longitudinal axis of the needle <b>116</b>′. In one embodiment, the distal face <b>119</b>′ may include a sharpened edge.
0046In one exemplary embodiment, the needle <b>116</b> is formed of an electrically conductive material so that, when the needle <b>116</b> contacts the first electrode <b>108</b>, the needle <b>116</b> is electrically activated. Those skilled in the art will understand that the needle <b>116</b> may, alternatively, be permanently mechanically coupled to a source of electric power and energized and de-energized via a switch on a handle or any other actuator. The needle <b>116</b> may include an insulated portion <b>134</b> along a portion of the needle <b>116</b> received within the handle assembly <b>132</b>. The insulated portion <b>134</b> may be insulated via, for example, an insulating sheath, or may be formed of a non-conductive material. The insulated portion <b>134</b> is positioned along the needle <b>116</b> so that, when the needle <b>116</b> is in the retracted bipolar configuration, the insulated portion <b>134</b> is proximal of the pad <b>138</b> and is not in contact therewith. When the needle <b>116</b> is moved distally relative to the handle assembly <b>132</b>, toward the extended monopolar configuration, however, the insulated portion <b>134</b> extends over the pad <b>138</b> to break the return path of the current, inactivating the second electrode <b>110</b>. Thus, moving the needle <b>116</b> to the extended configuration may automatically inactivate the return, causing the device <b>100</b> to be moved from the bipolar configuration to the monopolar configuration.
0047Although the return path is described as being broken by the movement of the needle <b>116</b> from the retracted configuration to the extended configuration, the return path may inactivated in any of a number of ways. For example, the return path may be disconnected by a pushbutton, toggle switch, or any other switching mechanism. It is not required that the longitudinal movement of the needle <b>116</b> relative to the catheter <b>102</b> facilitates the making/breaking of the return path.
0048According to an exemplary method using the device <b>100</b>, the catheter <b>102</b> is inserted into a patient's body along a tortuous path through, for example, a working channel of a flexible endoscope, until the distal tip <b>106</b> is proximate a target site. The catheter <b>102</b> is generally inserted to the target site with the needle <b>116</b> in the retracted configuration to avoid injury and/or damage to the working channel of the endoscope. Once the catheter <b>102</b> has reached the target site, the power source <b>136</b> may be powered on to supply energy to the first electrode <b>108</b>. Thus, when the distal tip <b>106</b> is pressed into contact with tissue at the target site, current is passed from the first electrode <b>108</b> to the second electrode <b>110</b> to heat and coagulate target tissue via a bipolar activation. Where it is desired to cut tissue at the target site, the needle <b>116</b> may be moved distally relative to the catheter <b>102</b> toward the extended configuration. As described above, extending the needle <b>116</b> inactivates the second electrode <b>110</b> to switch the device from the bipolar configuration to the monopolar configuration. In particular, when the needle <b>116</b> is extended distally past the distal opening <b>120</b> of the lumen <b>104</b> of the catheter <b>102</b>, the needle <b>116</b> contacts the first electrode <b>108</b> so that current passes to the needle <b>116</b> to provide a monopolar activation thereof. Thus, the needle <b>116</b> may be used to cut tissue at the target site.
0049In some embodiments, as would be understood by those skilled in the art, a stylet (not shown) may be received within the channel <b>122</b> of the needle <b>116</b> to prevent the collection of charred tissue therein during the cutting process. In other embodiments, as described above, fluid and/or drugs may be injected to the target site through the channel <b>122</b> of the needle <b>116</b>. Alternatively, vacuum pressure may be applied through the channel <b>122</b> to provide suctioning to the target site to draw tissue against the distal tip <b>106</b>. The device <b>100</b> may be moved between the retracted bipolar configuration and the extended monopolar configuration to coagulate and cut tissue, respectively, as desired. Once the target site has been treated, as desired, the power source <b>136</b> may be powered off and the needle <b>116</b> may be withdrawn proximally into the catheter <b>102</b> so that the device <b>100</b> may be removed from the body.
0050Although the needle <b>116</b> is described as formed of an electrically conductive material, in alternate embodiments, a needle of the device <b>100</b> may be formed of material that is not electrically conductive except that it will include small conductive portions in desired locations to facilitate cutting by increasing current density at these locations. For example, as shown in <figref idref="DRAWINGS">FIG. <b>7</b></figref>, a needle <b>116</b>′ may include metal strips <b>140</b>′ extending along a length thereof so that, when the needle <b>116</b>′ is extended distally past the distal opening <b>120</b> of the catheter <b>102</b>, the metal strips <b>140</b>′ are activated via the first electrode <b>108</b>. In another embodiment, as shown in <figref idref="DRAWINGS">FIG. <b>8</b></figref>, a needle <b>116</b>″ may include one or more conductive wings <b>140</b>″ extending from a non-conductive needle body <b>117</b>″. The needles <b>116</b>′ and <b>116</b>″ are exemplary only. Needles of the device <b>100</b> may have a variety of configurations for facilitating cutting via increasing a current density therealong.
0051In another embodiment, as shown in <figref idref="DRAWINGS">FIGS. <b>9</b>A-<b>9</b>E</figref>, a device <b>200</b> may be substantially similar to the device <b>100</b> comprising a catheter <b>202</b> including a lumen through which a needle assembly <b>215</b> is slidably received so that the needle assembly <b>215</b> is movable relative thereto between a retracted bipolar configuration and an extended monopolar configuration. The needle assembly <b>215</b> includes a first needle <b>216</b> and a second needle <b>242</b> slidably received within a channel <b>222</b> of the first needle <b>216</b>. The first needle <b>216</b> is substantially similar to the first needle <b>116</b> of the device <b>100</b>, as described above and, in this embodiment, includes either a tapered distal tip <b>218</b> (as shown in <figref idref="DRAWINGS">FIGS. <b>9</b>A and <b>9</b>B</figref>) or a non-tapered distal tip (as shown in <figref idref="DRAWINGS">FIGS. <b>9</b>C-<b>9</b>E</figref>). The second needle <b>242</b> may have a shape optimized for cutting efficiency and may be longitudinally movable relative to the first needle <b>216</b>.
0052In one exemplary embodiment, as shown in <figref idref="DRAWINGS">FIGS. <b>9</b>A-<b>9</b>C</figref>, the second needle <b>242</b> is configured as a cauterizing hook. In particular, a distal end <b>244</b> of the second needle <b>242</b> is bent relative to a remaining portion of a length thereof so that the second needle <b>242</b> is substantially hook-shaped. The first needle <b>216</b>, as shown in <figref idref="DRAWINGS">FIGS. <b>9</b>A-<b>9</b>B</figref>, includes a longitudinal slot <b>246</b> extending along a length thereof to accommodate the bent distal end <b>244</b> of the second needle <b>242</b> when the second needle <b>242</b> is moved relative to the first needle <b>216</b>. According to one example, as shown in <figref idref="DRAWINGS">FIG. <b>9</b>A</figref>, proximal movement of the second needle <b>242</b> relative to the catheter <b>202</b> and/or the first needle <b>216</b> may be restricted via a size and shape of an opening <b>220</b> of the lumen <b>204</b> at a distal end <b>228</b> of the catheter <b>202</b> so that the second needle <b>242</b> cannot be drawn into the lumen of the catheter <b>202</b>. According to another example, as shown in <figref idref="DRAWINGS">FIG. <b>9</b>B</figref>, the opening <b>220</b> at the distal end <b>228</b> of the lumen is sized and shaped to permit the bent distal end <b>244</b> of the second needle <b>242</b> to be drawn proximally into and out of the lumen <b>204</b>. According to yet another example, as shown in <figref idref="DRAWINGS">FIG. <b>9</b>C</figref>, in which the first needle <b>216</b> does not include a longitudinal slot, the second needle <b>242</b> may not be drawn entirely into the channel <b>220</b> of the first needle <b>216</b>.
0053Although <figref idref="DRAWINGS">FIGS. <b>9</b>A and <b>9</b>B</figref> show a hook-shaped distal end <b>244</b> of the second needle <b>242</b>, the distal end <b>244</b> of the second needle <b>242</b> may have any of a variety of configurations to optimize cutting efficiency. For example, the distal end <b>244</b> may have a cross-shape, as shown in <figref idref="DRAWINGS">FIG. <b>9</b>D</figref>, or a planar circular shape, as shown in <figref idref="DRAWINGS">FIG. <b>9</b>E</figref>. The described features for each of the catheter <b>202</b>, the first needle <b>216</b> and the second needle <b>242</b> should not be limited to the embodiments shown in the <figref idref="DRAWINGS">FIGS. <b>9</b>A-<b>9</b>E</figref>. Rather, the various features of the catheter <b>202</b>, the first needle <b>216</b> and the second needle <b>218</b> may be combined in any of a variety of different configurations, as desired.
0054Although the above exemplary embodiments describe moving the device between a bipolar coagulating configuration and a monopolar cutting configuration, in another embodiment, a distal tip of a catheter may be optimized for cutting so that a device may be movable between two cutting configurations. For example, as shown in <figref idref="DRAWINGS">FIG. <b>10</b></figref>, a device <b>300</b> may be substantially similar to the device <b>100</b> described above, comprising a catheter <b>302</b> including a distal tip <b>306</b> having a first (e.g., positive) and second (e.g., negative) electrode <b>308</b>, <b>310</b> extending thereabout. Although not shown, the device <b>300</b> may further comprise a needle received slidably therein so that the needle is movable between a retracted configuration, in which a distal end of the needle is proximal a distal end <b>328</b> of the distal tip <b>306</b>, and an extended configuration, in which the distal end of the needle is distal of the distal end <b>328</b> of the distal tip <b>306</b>. The catheter <b>302</b> is substantially similar to the catheter <b>102</b>. The distal tip <b>306</b>, however, is tapered via a single grind so that a distal end <b>328</b> tapers to a sharp tip <b>329</b>. The first electrode <b>308</b> extends to the sharp tip <b>329</b> to concentrate a current density thereto to facilitate a cutting via the catheter <b>302</b>. Thus, rather than achieving coagulation, as described above with respect to the device <b>100</b>, the catheter <b>302</b> may be used to cut tissue via the sharp tip <b>329</b>. The needle of the device <b>300</b> is therefore not required to cut tissue. In some embodiments, however, the needle may be moved between the retracted configuration, so that the catheter <b>302</b> may provide cutting, and the extended configuration, so that the needle provides cutting, to provide the device <b>300</b> with two cutting methods with two different cutting characteristics.
0055In another example, as shown in <figref idref="DRAWINGS">FIG. <b>11</b></figref>, according to a device that is substantially similar to the device <b>300</b> described above, a catheter <b>302</b>′ may include a distal tip <b>306</b>′ including first and second electrodes <b>308</b>′, <b>310</b>′ extending thereabout in a bipolar configuration. Similarly to the distal end <b>328</b> of the distal tip <b>306</b> described above, the distal end <b>328</b>′ of the distal tip <b>306</b>′ has a tapered distal end <b>328</b>′. The distal end <b>328</b>′, however, may be tapered to a sharp tip <b>329</b>′ via a double grind. Similarly to the distal tip <b>306</b>, the first electrode <b>308</b>′ extends to the sharp tip <b>329</b>′ to facilitate cutting thereby by concentrating a current density thereto.
0056Variations may be made in the structure and methodology of the present disclosure, without departing from the spirit and the scope of the disclosure. Thus, it is intended that the present disclosure cover the modifications and variations of this disclosure that may be contemplated by a person of skill in the art.
Contents5
9 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4 Sheet 5 Sheet 6 Sheet 7 Sheet 8 Sheet 9
Every citation, both ways
| Document | Relation | Office | Cited during |
|---|---|---|---|
| US2006189972A1 | Cites | United States of America | Search report |
| US2013178845A1 | Cites | United States of America | Search report |
| US4532924A | Cites | United States of America | Search report |
| US5342381A | Cites | United States of America | Search report |
| US5383876A | Cites | United States of America | Search report |
| US5683388A | Cites | United States of America | Search report |
| US7537595B2 | Cites | United States of America | Search report |
| US20060189972A1 | Cites | United States of America | Search report |
| US20130178845A1 | Cites | United States of America | Search report |
7 members in 1 office
Members7
| Document | Office | Kind | |
|---|---|---|---|
| US2017209207A1 | United States of America | A1 | |
| US10321952B2 | United States of America | B2 | |
| US2019254738A1 | United States of America | A1 | |
| US11534233B2This record | United States of America | B2 | |
| US2023116333A1 | United States of America | A1 | |
| US12226147B2 | United States of America | B2 | |
| US2025143780A1 | United States of America | A1 |
40 transactions on the USPTO file
Allowed after 1 non-final rejection.
- Non-final rejections
- 1
- Final rejections
- 0
- RCEs
- 0
- Appeals
- 0
Over time
Point at a mark for the transactionTransactions
| Event | Code | |
|---|---|---|
| Recordation of Patent Grant MailedPGM/ | PGM/ | |
| Patent Issue Date Used in PTA CalculationAllowedPTAC | PTAC | |
| Email NotificationEML_NTR | EML_NTR | |
| Issue Notification MailedAllowedWPIR | WPIR | |
| Dispatch to FDCD1935 | D1935 | |
| Application Is Considered Ready for IssuePILS | PILS | |
| Issue Fee Payment VerifiedN084 | N084 | |
| Issue Fee Payment ReceivedIFEE | IFEE | |
| Mail Post CardPST_CRD | PST_CRD | |
| Email NotificationEML_NTF | EML_NTF | |
| Mail Notice of AllowanceAllowedMN/=. | MN/=. | |
| Notice of Allowance Data Verification CompletedAllowedN/=. | N/=. | |
| Date Forwarded to ExaminerFWDX | FWDX | |
| Response after Non-Final ActionA... | A... | |
| Paralegal or electronic terminal disclaimer approvedP574 | P574 | |
| Terminal Disclaimer FiledDIST | DIST | |
| Electronic ReviewELC_RVW | ELC_RVW | |
| Email NotificationEML_NTF | EML_NTF | |
| Mail Non-Final RejectionNon-final rejectionMCTNF | MCTNF | |
| Non-Final RejectionNon-final rejectionCTNF | CTNF | |
| Case Docketed to Examiner in GAUDOCK | DOCK | |
| Case Docketed to Examiner in GAUDOCK | DOCK | |
| Case Docketed to Examiner in GAUDOCK | DOCK | |
| Case Docketed to Examiner in GAUDOCK | DOCK | |
| Email NotificationEML_NTR | EML_NTR | |
| Application ready for PDX access by participating foreign officesCCRDY | CCRDY | |
| PG-Pub Issue NotificationPG-ISSUE | PG-ISSUE | |
| Case Docketed to Examiner in GAUDOCK | DOCK | |
| Email NotificationEML_NTR | EML_NTR | |
| Application Is Now CompleteCOMP | COMP | |
| Filing ReceiptFLRCPT.O | FLRCPT.O | |
| Application Dispatched from OIPEOIPE | OIPE | |
| FITF set to YES - revise initial settingFTFS | FTFS | |
| Cleared by OIPE CSRL194 | L194 | |
| Patent Term Adjustment - Ready for ExaminationPTA.RFE | PTA.RFE | |
| PTO/SB/69-Authorize EPO Access to Search ResultsSREXR141 | SREXR141 | |
| Applicants have given acceptable permission for participating foreignAPPERMS | APPERMS | |
| IFW Scan & PACR Auto Security ReviewSCAN | SCAN | |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change)BIG. | BIG. | |
| Initial Exam Team nnIEXX | IEXX |
7 legal events, as the office reported them to INPADOC
Over the term
Point at a mark for the eventEvents
| Event | Code | |
|---|---|---|
| Maintenance fee paymentMAFP | MAFP | |
| Information on status: patent grantGrantedPATENTED CASESTCF | STCF | |
| Information on status: patent application and granting procedure in generalPUBLICATIONS -- ISSUE FEE PAYMENT VERIFIEDSTPP | STPP | |
| Information on status: patent application and granting procedure in generalNOTICE OF ALLOWANCE MAILED -- APPLICATION RECEIVED IN OFFICE OF PUBLICATIONSSTPP | STPP | |
| Information on status: patent application and granting procedure in generalRESPONSE TO NON-FINAL OFFICE ACTION ENTERED AND FORWARDED TO EXAMINERSTPP | STPP | |
| Information on status: patent application and granting procedure in generalNON FINAL ACTION MAILEDSTPP | STPP | |
| Fee payment procedureENTITY STATUS SET TO UNDISCOUNTED (ORIGINAL EVENT CODE: BIG.); ENTITY STATUS OF PATENT OWNER: LARGE ENTITYFEPP | FEPP |
Numbers
- Publication
- 11534233
- Application
- 16400575
Titles
- English
- Medical device capable of injection, cutting and coagulation
Patent term adjustment
- A delay
- +670 daysthe office missed an examination deadline
- B delay
- +240 dayspendency past three years
- Net adjustment
- 910 days
Classification
- CPC, 10
- A61B18/1477
- A61B2018/1253
- A61B2018/126
- A61B18/1206
- A61B2018/1425
- A61B2018/00601
- A61B2018/1427
- A61B2018/1435
- A61B2018/1475
- A61B2217/007
- IPC, 3
- A61B18 12
- A61B18 14
- A61B18 00